Formulation and process optimization of Etodolac extended release tablet
The aim of the present study was to optimize Etodolac extended release(ER) tablets meet the international regulatory requirements and prove with assurance, that the product meets predetermined specifications and quality attributes. In present research work, the optimization of compression process and granulation has been carried out using rapid mixer granulator and cadmach 16 station single rotary machine. Granulation process variables like impeller speed, chopper speed, binder addition time, ampere reading were selected Drying process variables as Initial air-drying time, Total Hot air drying Time, Inlet Temperature (°C) Outlet Temperature (°C) were selected and their impact on bulk density, true density, compressibility index hausner ratio and loss on drying. Compression process variable was carried out at by using BOX AND BEHNKEN experimental design and evaluated for weight variation, Hardness, Thickness, Friability and dissolution studies. Results indicated that uniform granules formation was observed at fast impeller speed , slow chopper speed ampere reading of 3.7-4.1, dry mixing for 7 minutes, relative standard deviation was less, which indicates that the homogecity of drug distribution in the dry mixture. At 20 rpm Machine speed, Tablet thickness was found between - 6.2-6.6 mm, Hardness of Tablet NLT 6 kg/c, Optimized tablet coating was carried out in perforated Coating pan and drug release was found to be 92.6 % at 16 hrs. It can be concluded that granulation and compression process optimization of Etodolac extended release tablet can be successfully prepared and evaluated.
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